Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus
This trial has been completed.
|Condition||type 1 diabetes|
|Phase||phase 1/phase 2|
|Sponsor||University of California, San Francisco|
|Collaborator||Juvenile Diabetes Research Foundation|
|Start date||February 2004|
|End date||December 2016|
|Trial size||30 participants|
|Trial identifier||NCT00501709, 39-42C|
Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: monthly
Male or female participants from 18 years up to 65 years old.
- Type 1 Diabetes
- Metabolic lability/instability characterized by hypoglycemia or ketoacidosis(>2 hospital admissions in the previous year), erratic glucose profiles(MAGE >120mg/dL), or disruption in lifestyle(danger to life, self or others). Reduced awareness of hypoglycemia or > 1 episode in the last 1.5 years of severe hypoglycemia.
- Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of intensive management efforts with diabetes care team.
- Progressive secondary complications as defined by
- a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or
- urinary albumin excretion rate >300mg/day but proteinuria <3g/day; or
- symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)
- Patient weighs more than 80kg or body mass index BMI>28
- Patient's insulin requirement is >55 Units/day.
- Current use of immunosuppressive agents.
- History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin).
- Active peptic ulcer disease.
- Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications.
- Untreated proliferative retinopathy.
- Pregnancy or breastfeeding.
- Female subjects not post-menopausal or surgically sterile, or not using an acceptable method or contraception.
- Active infections.
- Major ongoing psychiatric illness.
- Ongoing substance abuse, drug or alcohol; or recent history of noncompliance.
- Portal hypertension or history of significant liver disease.
- Lymphopenia (<1000/ul) or leukopenia (<3000 total leukocytes/ul) or an absolute CD4 count <500/ul.
- Presence or history of panel-reactive anti-HLA antibody >20%.
- Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM).
- Serologic evidence of infection with HIV or HbsAg or HCV Ab positive.
- Creatinine clearance <60ml/min/m2.
- Positive lymphocytoxic cross-match using donor lymphocytes and serum
|Principal investigator||Peter G Stock, M.D., Ph.D.|
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